caa a22 4500 445335963 CHVBK 20180317142755.0 cr unu---uuuuu 170323e20110401xx s 000 0 eng 10.1245/s10434-010-1401-9 doi (NATIONALLICENCE)springer-10.1245/s10434-010-1401-9 Phase II Study of Gemcitabine and Erlotinib as Adjuvant Therapy for Patients with Resected Pancreatic Cancer [Elektronische Daten] [Philip Bao, Ramesh Ramanathan, Alyssa Krasinkas, Nathan Bahary, Barry Lembersky, David Bartlett, Steven Hughes, Kenneth Lee, A. Moser, Herbert Zeh III] Background: There is currently no consensus about the most effective adjuvant therapy for adenocarcinoma of the pancreas. Both gemcitabine and erlotinib have been demonstrated to improve survival in patients with metastatic disease. This study was designed to evaluate the efficacy of gemcitabine and erlotinib as adjuvant therapy, and to explore potential biomarkers associated with response. Methods: An institutional review board-approved single-center phase II trial of adjuvant biweekly fixed-dose rate gemcitabine (1500mg/m2) and daily erlotinib (150mg/day) for 4months followed by maintenance erlotinib (150mg/day) over 8months was initiated. Primary end point was recurrence-free survival (RFS). Epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). Results: The study completed planned accrual of 25 patients. Median follow-up was 18.2 (range 11.6-23.5) months. Recurrences were observed in 17 subjects (68%). Median RFS was 14.0months (95% confidence interval [95% CI], 8.2-24.5) with 1-year and 2-year RFS of 56% (95% CI, 35-73) and 26% (95% CI, 6-52), respectively. Median overall survival was not reached. Estimated 1-year and 2-year overall survival was 84% (95% CI, 63-94) and 53% (95% CI, 22-76), respectively. Nine patients (36%) had a grade 3 event and only 1 (4%) had a grade 4 (neutropenia). Most toxicities were dermatologic, gastrointestinal, and constitutional. There were nonsignificant trends to longer RFS and lower recurrence rates while receiving therapy in subjects with fluorescence in situ hybridization-positive tumors and greater immunohistochemistry expression. Conclusions: Our phase II results suggest that adjuvant gemcitabine and erlotinib is a promising regimen that merits further investigation. Society of Surgical Oncology, 2010 Bao Philip Department of Surgery, Stony Brook University Hospital, Stony Brook, NY, USA aut Ramanathan Ramesh Virginia G. Piper Cancer Center, Scottsdale, AZ, USA aut Krasinkas Alyssa Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Bahary Nathan Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Lembersky Barry Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Bartlett David Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Hughes Steven Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Lee Kenneth Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Moser A. Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Zeh III Herbert Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Annals of Surgical Oncology Springer-Verlag 18/4(2011-04-01), 1122-1129 1068-9265 18:4<1122 2011 18 10434 https://doi.org/10.1245/s10434-010-1401-9 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1245/s10434-010-1401-9 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Bao Philip Department of Surgery, Stony Brook University Hospital, Stony Brook, NY, USA aut NATIONALLICENCE 700 1- Ramanathan Ramesh Virginia G. Piper Cancer Center, Scottsdale, AZ, USA aut NATIONALLICENCE 700 1- Krasinkas Alyssa Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Bahary Nathan Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Lembersky Barry Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Bartlett David Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Hughes Steven Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Lee Kenneth Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Moser A. Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Zeh III Herbert Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 773 0- Annals of Surgical Oncology Springer-Verlag 18/4(2011-04-01), 1122-1129 1068-9265 18:4<1122 2011 18 10434 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer